Trifocal Intraocular Lens (IOL) Aberrometry Outcomes

Spectacle Independence After Implantation of Trifocal and Trifocal Toric Intraocular Lenses Using Intraoperative Aberrometry: A Prospective Analysis

The goal of this study is to evaluate subject outcomes and spectacle independence with intraoperative aberrometry and trifocal IOL implantation.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: Alcon Trifocal and Trifocal Toric Intraocular Lenses

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Weill Cornell Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects with a diagnosis of visually-significant cataracts who meet the inclusion and exclusion criteria will be eligible for participation in this study.

Description

Inclusion Criteria:

• Able to consent to study and cataract surgery
• Visually significant cataract
• Potential post-operative visual acuity of 20/25 or better
• Age 18 years or older

Exclusion Criteria:

• Ocular pathology contraindicated for trifocal IOLs including but not limited to diabetic retinopathy, age-related macular degeneration or other macular pathology, cornea guttata, corneal scarring, corneal ectasia, glaucoma with visual field loss
• Irregular astigmatism
• Prior corneal refractive surgery

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
trifocal intraocular lens	Device: Alcon Trifocal and Trifocal Toric Intraocular Lenses; Panoptix Model #TFAT00 for the UV Absorbing Trifocal IOL. Torics: TFAT30, TFAT40, TFAT50, TFAT60

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of spectacle independence (overall)	This will be assessed by a Visual Quality Questionnaire, an 18 question multiple choice questionnaire to assess vision-related functioning. Grading scale: 0, no difficulty; 1, a little difficulty; 2, moderate difficulty; 3, quite difficult; 4, impossible to perform. Mean value(s) will be analyzed.	1 month post-cataract surgery
Percentage spectacle independence (overall)	This will be assessed by a Visual Quality Questionnaire, an 18 question multiple choice questionnaire to assess vision-related functioning. Grading scale: 0, no difficulty; 1, a little difficulty; 2, moderate difficulty; 3, quite difficult; 4, impossible to perform. Mean value(s) will be analyzed.	3 months post-cataract surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spectacle independence for distance, intermediate and near	This will be assessed by a Visual Quality Questionnaire, an 18 question multiple choice questionnaire to assess vision-related functioning. Grading scale: 0, no difficulty; 1, a little difficulty; 2, moderate difficulty; 3, quite difficult; 4, impossible to perform. Mean value(s) will be analyzed.	1 month post-cataract surgery
Spectacle independence for distance, intermediate and near	This will be assessed by a Visual Quality Questionnaire, an 18 question multiple choice questionnaire to assess vision-related functioning. Grading scale: 0, no difficulty; 1, a little difficulty; 2, moderate difficulty; 3, quite difficult; 4, impossible to perform. Mean value(s) will be analyzed.	3 months post-cataract surgery
Spectacle independence subgroup analysis for subjects within 0.50 D spherical equivalent (SE)	This will be assessed by a Visual Quality Questionnaire, an 18 question multiple choice questionnaire to assess vision-related functioning. Grading scale: 0, no difficulty; 1, a little difficulty; 2, moderate difficulty; 3, quite difficult; 4, impossible to perform. Mean value(s) will be analyzed.	1 month post-cataract surgery
Spectacle independence subgroup analysis for subjects within 0.50 D spherical equivalent (SE)	This will be assessed by a Visual Quality Questionnaire, an 18 question multiple choice questionnaire to assess vision-related functioning. Grading scale: 0, no difficulty; 1, a little difficulty; 2, moderate difficulty; 3, quite difficult; 4, impossible to perform. Mean value(s) will be analyzed.	3 months post-cataract surgery
Binocular, uncorrected distance visual acuity for patients within 0.50 D of intended target	This will be measured by visual acuity	3 months post-cataract surgery
Subject satisfaction	This will be assessed by a Visual Quality Questionnaire, an 18 question multiple choice questionnaire to assess vision-related functioning. Grading scale: 0, no difficulty; 1, a little difficulty; 2, moderate difficulty; 3, quite difficult; 4, impossible to perform. Mean value(s) will be analyzed.	3 months post-cataract surgery
Uncorrected binocular and monocular visual acuity at all distances	This will be measured by visual acuity	3 months post-cataract surgery
Distribution of residual refractive error	This will be measured by refractive error	3 months post-cataract surgery
Contrast sensitivity (binocular)	This will be measured by contrast sensitivity testing	1 month post-cataract surgery
Contrast sensitivity (binocular)	This will be measured by contrast sensitivity testing	3 months post-cataract surgery
Percentage of subjects with <=0.50 D of refractive cylinder	This will be measured by refractive error	1 month post-cataract surgery
Percentage of subjects with <=0.50 D of refractive cylinder	This will be measured by refractive error	3 months post-cataract surgery

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: Alcon Research
• Investigators: Principal Investigator: Ashley Brissette, MD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2019
• Primary Completion (Actual): September 13, 2022
• Study Completion (Actual): September 13, 2022

Study Registration Dates

• First Submitted: December 10, 2019
• First Submitted That Met QC Criteria: December 10, 2019
• First Posted (Actual): December 12, 2019

Study Record Updates

• Last Update Posted (Actual): December 15, 2022
• Last Update Submitted That Met QC Criteria: December 14, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: aberrometry; trifocal lens; trifocal intraocular lens
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 19-05020251

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No